Model Number N/A |
Device Problem
Dull, Blunt (2407)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/11/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.The user facility is foreign; therefore a facility medwatch report will not be available.Report source ¿ (b)(6).
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Event Description
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It was reported the screws did not enter the bone when the driver was turned.No adverse events have been reported as a result of the malfunction.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The complaint is confirmed.The qty two ster trc xd tf 1.5x4.0mm scr (part# sp-st-6704, lot# 355860) were returned for investigation.A visual inspection was conducted.The screw tips show signs of wear.Functional testing was completed by attempting to insert the screws into a piece of white oak wood using a 01-7390 driver handle lot 048760 with a 15-1196 1.5mm bit lot number 406650.When an attempt was made to turn the screws into the wood the screw tips were unable to penetrate the wood surface.The dhr was reviewed and there were no non-conformances found.There are no indications of manufacturing defects.For this part (sp-st-6704) and the previous one year (from the notification date) regarding the slipping of this screw, there is a complaint rate of 0.15% which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint is excessive force applied during an insertion attempt, beyond what the implant is designed to encounter.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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This follow-up report is being submitted to relay additional information.
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Search Alerts/Recalls
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